QA Principal Scientist Validation

Bagsværd

Would you like to be part of expanding our capacities to support the company portfolio of future oral and injectable pharmaceuticals? Are you excited at the prospect of designing new projects to shape the way we assure quality? Ready to make your part to bring new innovative treatments to patients worldwide?
If yes, read more and apply now!

The position [xxxxx] is establishing new, ground-breaking biotech facilities utilising modern technology with fully automated operations and digitalised processes; they will be situated in Denmark and abroad and must be designed in accordance with GMP requirements (Good Manufacturing Practice) and upon maturing of the projects, you will take part in a successful handover to the local project QA organisation. As a QA Validation Specialist, you will be responsible for supporting our expansion projects with input to validation strategy and quality risk assessments, with competence building in our QA project organisation and contribute to the [xxxxx] Validation process.
  • Provide guidance on validation strategy
  • Support local project QA
  • Interact with stakeholders at all levels of the organisations to ensure robust work methods are in place within the validation process
  • Provide training and support to building competences within the organisation
  • You will be connected to our investment projects, where your deep knowledge will come into play, when designing solutions for new facilities, starting from the very early phases, and continuing all the way through to final validation and transferring the facilities into operation. Qualifications
    This role will have you be at the centre of leading and decision making in a high complexity landscape for building and then develop and maintain new facilities, for this reason the ideal candidate has a robust personality, is good at building relations and creating trust and is able to proactively set clear direction within the quality agenda.
    To succeed in this role, you:
  • Hold a Master’s degree within science or equivalent
  • Have at least 5 years of experience within QA or validation
  • Have gained said experience from the pharmaceutical industry
  • Have solid communication skills
  • Full English proficiency

  • Experience within the fields of Validation, Quality Risk Management & Risk Processes and Engineering is an advantage.
    On a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, when the waves get high. You thrive in a multicultural environment working across organisational borders and management levels. Building structures comes naturally to you and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner. About the department
    Investment Portfolio QA Support works to ensure early involvement in the capacity expansion portfolio in Novo Nordisk.
    Through our responsibility and collaboration with project organisations and stakeholders, we oversee compliance, timely approval in the establishment of new facilities built with new technology and ultimately securing products with the highest quality to patients.
    The department works across all Novo Nordisk sites as proximity to the projects is important. Working at [xxxxx]
    At [xxxxx], we always strive for excellence and continuously develop our expertise to stay ahead - both as a company and as individuals. We believe that innovation and creativity thrive in a healthy and engaging working environment. Therefore, we give you the opportunity to bring your personal ambition and passion to work to improve the quality of life of the patients. Contact
    For further information, please contact Tine Kranker on +[xxxxx] Deadline
    16th June 2024. Note that applications will be reviewed on an ongoing basis and the position will be closed when we find the right candidate.
    You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV
    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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